Vacuum Regulator, Push-T-Set Intermittent Suction Unit (PTS-ISU) Product Usage: The vacuum regulator is intended to be used in a medical facility as a means to evacuate media (i.e. fluids) from the body.
Check against the official notice below — it lists the full affected range.
Ohio Medical Corporation is recalling 11 units of its Vacuum Regulator, Push-T-Set Intermittent Suction Unit (PTS-ISU), which is used in medical facilities to evacuate media. The recall was initiated because final quality control testing was not completed before the devices were distributed. The affected devices were distributed nationwide in North Carolina, Indiana, Tennessee, Louisiana, Florida, Michigan, and Illinois, with specific lot numbers and unit identifiers documented for identification purposes.
The source document does not specify a remedy or any action that affected consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
Final quality control testing was not completed before the devices were distributed..
Reason for recall: Final quality control testing was not completed before the devices were distributed.. Distribution: US Nationwide Distribution in the states of NC, IN, TN, LA,, FL MI, IL. Quantity: 11 units Lot/code info: UDI 08688250002085; Catalog Numbers 8702-1251-908, 8701-1251-901, 8705-1251-907, 8701-1251-908, 8705-1251-901; Lot Number ISU177359; Device Unit Numbers JGGW24156, JGGW24193, JGGW24157, JGGW24161 ,JGGW24167, JGGW24169, JGGW24175, JGGW24188, JGGW24189, JGGW24198, JGGW24160
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.